BILL NUMBER: SB 747	AMENDED
	BILL TEXT

	AMENDED IN SENATE  APRIL 15, 2013

INTRODUCED BY   Senator DeSaulnier

                        FEBRUARY 22, 2013

   An act to add Article 6 (commencing with Section 108670) to
Chapter 5 of Part 3 of Division 104 of the Health and Safety Code,
relating to public health.



	LEGISLATIVE COUNSEL'S DIGEST


   SB 747, as amended, DeSaulnier. Public Health Impact Report.
   Existing law requires the State Department of Public Health to
regulate various consumer products, including food and drugs, for the
protection of the people of the state.
   This bill, known as the Public Health Epidemic Protection Act of
2013, would require the  department, for every product
intended for consumer consumption for which it has credible evidence
that the product significantly contributes to a significant public
epidemic, to conduct a risk assessment evaluation to determine
whether the product contributes significantly to a significant public
health epidemic, as defined, and whether the adverse public health
risk would have a fiscal impact on the state of $50,000,000 or more.
The bill would authorize the department to charge the manufacturer of
the product for the reasonable costs of producing the risk
assessment and would create the Public Health Fund, to be used by the
department, upon appropriation by the Legislature, to fund the
program. If the department determines that the criteria are met, the
bill would   department to  require the
manufacturer  of a contributing product, as defined,  to
create, for approval of the department, a public health impact report
(PHIR) containing specified information, including a list of adverse
public health impacts and a mitigation plan for those impacts. The
bill would authorize the department to enforce the PHIR and would
authorize the department to restrict or suspend sales of the product
in the state if the PHIR is insufficient or if the manufacturer is
not complying with the terms of the PHIR.  The   bill
would authorize the department to charge the manufacturer of the
product for the reasonable costs of reviewing, approving, and
enforcing the PHIR requirements. 
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  The Legislature finds and declares all of the
following:
   (a) Public health for the people of the state is now, and in the
future, a matter of statewide concern.
   (b) The health and well-being of all people is a critical element
in supporting a healthy and prosperous California, including economic
sustainability, increasing workforce participation and productivity,
and slowing the ongoing rise of medical care expenditures.
   (c) California and its residents face a growing burden of largely
preventable chronic illness, including heart disease, stroke,
obesity, and diabetes.
   (d) It is the intent of the Legislature to find ways to develop
and maintain public health, prevent negative public health risks,
provide the people of the state with protection from products sold in
the state that pose significant negative health risks, and 
development   develop  mitigation strategies.
   (e) It is the intent of the Legislature to take immediate steps to
identify products sold in the state for consumer consumption that
pose a critical public health risk and coordinate any actions
necessary to prevent or mitigate those risks.
   (f) It is the intent of the Legislature to regulate products sold
in the state for consumer consumption that pose significant public
health risks and mitigate their use in order to prevent chronic
illness and improve public health.
  SEC. 2.  Article 6 (commencing with Section 108670) is added to
Chapter 5 of Part 3 of Division 104 of the Health and Safety Code, to
read:

      Article 6.  Public Health Impact Assessments


   108670.  This article shall be known, and may be cited, as the
Public Health Epidemic Protection Act of 2013. 
   108671.  (a) The State Department of Public Health shall, for
every product intended for consumer consumption that the department
has credible evidence that the product significantly contributes to a
significant public epidemic, conduct a risk assessment evaluation.
The department, in doing the risk assessment evaluation, shall use
currently available research, data, and studies to determine the
following:
   (1) If the product contributes significantly to a significant
public health epidemic, as recognized by the federal Centers for
Disease Control and Prevention.
   (2) If there is evidence that the adverse public health risk would
have a fiscal impact on the state of fifty million dollars
($50,000,000) or more.
   (b) The department may charge the manufacturer of the product for
the reasonable costs of producing the risk assessment pursuant to
this section. Fees collected pursuant to this subdivision shall be
placed in the Public Health Fund, which is hereby established in the
State Treasury and which may be used by the department, upon
appropriation by the Legislature, for the implementation of this
article.  
   108671.  For the purposes of this article, the following
definitions shall apply:
   (a) "Contributing product" means a product intended for consumer
consumption in this state for which the department has credible
evidence that use of the product significantly contributes to a
public health epidemic and that meets both of the following criteria:

   (1) The public health epidemic to which the product contributes is
one recognized by the federal Centers for Disease Control and
Prevention.
   (2) The adverse impact on public health from use of the product in
this state would have a fiscal impact of fifty million dollars
($50,000,000) or more annually.
   (b) "Credible evidence" means research, data, and studies
currently available to the department.
   (c) "Department" means the State Department of Public Health.

   108672.  (a) If  a risk assessment determines that the
product meets both of the requirements in subdivision (a) of Section
108671,   the department determines that a product is a
contributing product then  the department shall require the
product's manufacturer to create a public health impact report
(PHIR). The PHIR shall be submitted to the department for approval.
   (b) The PHIR shall include all of the following:
   (1) A list of adverse public health impacts that cannot be avoided
if the product is sold in the state.
   (2) The benefits, costs, and alternatives to the  consumer
  contributing  product.
   (3) Alternatives available, if any.
   (4) A mitigation plan sufficient to minimize the adverse public
health impacts identified in paragraph (1).
   (c) The department may take actions necessary to enforce the PHIR,
including, but not limited to, requiring that the manufacturer
establish a trust or place moneys in escrow sufficient to cover the
estimated costs of implementation.
   (d) If the department determines that the PHIR prepared by the
manufacturer is insufficient or that the manufacturer is not
complying with the terms of the PHIR, then the department may
restrict or prohibit the sale of the product in this state.
   108673.  The department shall enact all regulations necessary to
implement this article pursuant to the Administrative Procedure Act
(Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code). 
   108674.  The department may charge the manufacturer of the product
for the reasonable costs of reviewing, approving, and enforcing the
PHIR requirements. Fees collected pursuant to this subdivision shall
be placed in the Public Health Fund, which is hereby established in
the State Treasury and which may be used by the department, upon
appropriation by the Legislature, for the implementation of this
article.  
   108675.  Notwithstanding subdivision (c) of Section 25257.1, the
requirements of this article shall not be interpreted to affect any
authority of the Department of Toxic Substances Control pursuant to
Article 14 (commencing with Section 25251) of Chapter 6.5 of Division
20.